Therion cancer vaccine shows anti-tumor activity

The phase I study evaluated multiple dosing regimens of the CEA-TRICOM vaccines in 58 patients with advanced CEA-expressing tumors. Investigators found that disease stabilization was achieved for at least four months in 40% of the study participants, and for more than six months in 24% of the participants.

One patient with small cell lung cancer achieved a complete response, with no evidence of cancer after several months of vaccination, and side effects were primarily skin reactions at the site of vaccination and temporary flu-like symptoms after each vaccination.

Therion’s lead therapeutic vaccine targeting CEA-expressing tumors is PANVAC-VF, which has the potential to extend survival in patients with pancreatic cancer by activating the proliferation of an array of cytotoxic T cells necessary to selectively target and destroy tumors. PANVAC-VF is in a phase III clinical trial for the treatment of metastatic pancreatic cancer in patients who have previously received gemcitabine (marketed as Gemzar by Eli Lilly).

“These results support the ability of the CEA-TRICOM vaccines to mount significant specific immune responses,” said Dr John Marshall, associate professor of medicine at Georgetown University. “Furthermore, the study provided an early indication that the CEA-TRICOM vaccine may slow the progression of disease in patients with advanced cancers and underscores the benefit that such therapeutic vaccines may provide in the fight against cancer.”

“This study was an important part of the body of data that enabled us to optimize PANVAC-VF now in a phase III pivotal trial,” added Mark Leuchtenberger, president and CEO of Therion. “Assuming results are positive, we expect to submit a biologics license application (BLA) in 2006.”